Elarekibep

Pieris is on the hunt for new collaborations after AstraZeneca stepped away from a partnered asthma med. AstraZeneca has sailed away from a licensing deal for Pieris Pharmaceuticals’ asthma med, forcing the biotech to begin charting a new corporate course and lay off 70% of its staff in the process. The Boston-based company said Tuesday that AstraZeneca has terminated the partnership for elarekibep, a month after the Big Pharma stopped dosing of a trial following concerning nonclinical toxicology data. Pieris said today that AstraZeneca has also stepped away from “the remaining discovery program.”  AstraZeneca’s decision has thrust Pieris into deep water without a life preserve, with the biotech shedding 70% of staff to stay afloat. The Big Pharma originally handed over $45 million in 2017 to partner up on the then-preclinical elarekibep.  Pieris, armed with $54.9 million in cash as of the end of June, was blunt in its assessment of future moves, saying explicitly that it’s on the hunt for new partnerships for its existing pipeline. That includes PRS-220, a phase 1 inhaled Anticalin protein targeting connective tissue growth factor to treat idiopathic pulmonary fibrosis. But that trial appears to have stalled, with no update made to the clinical trial record since November 2022 even though the primary completion date was earlier in June. The company hoped to enroll 64 patients in the single and multiple ascending dose study.  The biotech said it’s also looking to partner out its bispecific protein cinrebafusp alfa and PRS-400, another respiratory med aimed at muco-obstructive lung diseases. Should Pieris successfully find partners, that would leave it with little-to-no wholly-owned programs in its pipeline.  The end result may ultimately be a larger transaction than just one or two new partnerships. Pieris says it’s looking at all options, including an acquisition or merger. The company’s share price, already in the basement, ticked up marginally on today's announcement.  It’s a disappointing update for a company that had accrued significant validation through licensing deals, namely for its immuno-oncology pipeline. Pieris has two ongoing deals with Seagen, including one clinical-stage asset, PRS-346, and another with Servier for phase 1-stage PRS-344. A fourth pact with Boston Pharmaceuticals involves preclinical med PRS-342.   

Pieris Pharmaceuticals announced on Tuesday that it would cut around 70% of its staff and explore strategic options due to events that have impacted its inhaled respiratory franchise, including AstraZeneca's discontinuation of a Phase IIa study for elarekibep in asthma. The company added that the UK drugmaker has now decided to terminate its agreement for the IL-4 receptor alpha inhibitor, which was signed in 2017, handing back rights to the inhaled Anticalin therapy."We are pursuing strategic options across three main areas," explained CEO Stephen Yoder, adding that "one track is accelerating partnering discussions of PRS-220 and PRS-400," which are inhaled Anticalin proteins in preclinical trials for respiratory diseases. The company is also focused on selecting a development partner and deal structure to re-initiate clinical development of its former lead immuno-oncology asset cinrebafusp alfa.The drug, also known as PRS-343, has shown potential in a HER2+ gastric cancer trial, but "was discontinued for strategic reasons" last year. Yoder added "third, we will explore whether our balance sheet, position as a public company, and other assets are of strategic value to a range of third parties."Pieris currently has cash, cash equivalents and investments totalling $54.9 million, with the workforce cuts set to reduce cash spending. The company noted that it does not intend to make any further disclosures regarding the strategic review process until a specific course of action has been decided.